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Trial registered on ANZCTR


Registration number
ACTRN12619000750189
Ethics application status
Approved
Date submitted
10/04/2019
Date registered
20/05/2019
Date last updated
20/05/2019
Date data sharing statement initially provided
20/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial of Advanced CT Imaging and Combined Education Support for stroke patient access to reperfusion therapies
Scientific title
Trial of Advanced CT Imaging and Combined Education Support for stroke patient access to endovascular therapy (EVT) using a hub and spoke model of care
Secondary ID [1] 297537 0
None
Universal Trial Number (UTN)
U1111-1230-4161
Trial acronym
TACTICS (Trial of Advanced CT Imaging and Combined education Support)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 311749 0
Condition category
Condition code
Stroke 310385 310385 0 0
Ischaemic
Public Health 311295 311295 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BASELINE, INTERVENTION AND POST-INTERVENTION PERIODS

Stroke care data including acute case data, process times, advanced imaging profile, stroke reperfusion treatment, inter-hospital transfer of care and haemorrhage transformation will be obtained for a 9 month period (3 months baseline, 3 months intervention, 3 months post-intervention) for each cluster.

BASELINE PERIOD

Installation of AutoMIStar software; situational analysis of ‘status quo’; and commencement of TACTICS data collection mechanisms. Cluster stroke reperfusion therapy co-ordinators in each cluster, site champions and acute stroke access teams at each hospital will be identified.

Situational analysis of ‘status quo’
The 3-month baseline phase will involve individual site meetings along with review of multimodal CT image analysis software and stroke reperfusion protocols and processes at each site. This, together with voluntary staff surveys and key informant interviews regarding individual, social context and health system factors relating to acute stroke care, will form the basis of a site readiness assessment for each site, in order to establish a ‘status quo’ prior to implementing the study intervention. Interviews will be conducted both individually and as a group and will be tape-recorded.

Theoretical framework
Concepts from the Theoretical Domains Framework (TDF) and the Capability, Opportunity, Motivation and Behaviour (COM-B) approach will underpin the design, implementation and evaluation of the TACTICS ‘package intervention’ towards optimised workflow and patient selection for stroke reperfusion therapy.

Development of the ‘package intervention’
The TACTICS ‘package intervention’ will include didactic and interactive educational elements delivered by members of the research team and key stakeholders through a face to face cluster workshop, collaborative cluster teleconferences, ad hoc site meetings , a training manual or similar resource developed by the research team at The University of Newcastle, and case scenarios (via virtual reality technology or other method).

The package will include: (i) the rationale behind advanced imaging (CTA & CTP); (ii) utilisation of the AutoMIStar software, which is essentially automated but the user can alter the output at a variety of steps if they choose. (iii) interpretation of advanced imaging output (CTA & CTP); (iv) criteria relating to patient selection, based on core/penumbra maps and angiography to identify patients with high likelihood of good and poor response to IVT; and (v) assessment of each site’s current multimodal CT acquisition protocols by an experienced CT radiographer from the research team.
The AutoMIStar software is a medical image processing software that allows the advanced visualization and analysis of perfusion and diffusion images. The software provides the user with a set of metrics allowing the investigator to adopt an evidence based approach selection of patients to treatment. Evidence from research randomised clinical trials or reperfusion therapy has indicated the need for penumbra imaging profiling of patients in the selection for therapy.
The package will also include: (i) a template set of consensus clinical pathways and protocols towards optimal stroke reperfusion workflow; (ii) review of current cluster workflow using process mapping methodology; (iii) identifying gaps between current and ideal workflow; (iv) brainstorming around barriers and potential solutions; (v), prioritising change effort based on feasibility and importance; and (vi) developing an action plan, and vii) monitoring progress by reviewing site and cluster specific processes and mechanisms including progress towards action plan goals. Sites will be encouraged to capture, review and use their own data and current protocols and pathways to look at process measures such as door-in-door-out (DIDO) and door-to groin (DTG) treatment times, which will be supported by educational and problem-solving elements and a template set of evidence based tools and resources to boost capability, motivation and opportunity of acute stroke access teams to make improvements within their cluster towards an optimal stroke reperfusion workflow.

INTERVENTION PERIOD

Rollout and tailoring of the ‘package intervention’
The ‘package intervention’ will be delivered based on the rollout schedule by key stakeholders, opinion leaders and member of the research team with expertise in acute stroke care, advanced imaging interpretation, workflow optimisation, adult education (andragogy) and behaviour change at individual, social context and health system levels. To ensure relevance of the ‘package intervention’ for each Cluster, the package will be tailored to the specific context and needs of each Cluster. The site assessment at baseline and the outcomes of the initial Cluster workshop will assist with this. Engagement with key stakeholders, including hospital quality improvement/governance, will be emphasised throughout the trial.

Target audience of the ‘package intervention’
The target audience of the ‘package intervention’ will be the site champions and ASAT at each hospital, the Cluster coordinator in each Cluster and key staff involved in the processes of care from hospital arrival through to treatment / transfer to hub for EVT. Each Cluster will also be provided with recommendations of available acute stroke educational resources, which can be accessed and utilised by each hospital for educating new and rotating staff in acute stroke care.

Cluster workshop
One 2-day cluster workshop will be conducted face to face at the beginning of the intervention phase in each cluster.

The cluster workshop will involve didactic and interactive components delivered by key stakeholders, opinion leaders and members of the research team. Intervention elements will include process and pathway analysis; roles and responsibilities around communication and engagement within and between teams regarding cases, and process of care, the role of site champions and ASAT in motivating and driving change efforts within the cluster; and criteria for patient selection and contacting the hub physician on call. Activities will include review of current acute stroke reperfusion workflow within the cluster, review of ideal workflow, gap analysis, identification of barriers and prioritising solutions and strategies based on process outlining importance and feasibility. Educational elements will include advanced imaging; criteria for patient selection and contacting the hub physician on call; data capture, review and use of the TACTICS eCRF; strategies to optimise workflow and overview of TACTICS resource kit. The outcome of the workshop will be the development of an action plan with agreed action goals tailored to the cluster environment, based on strategies identified as important and achievable.

Cluster teleconferences
Three 1-hour cluster meetings conducted as teleconferences, videoconferences or a combination of these modalities will be held during the intervention phase of the study.
The cluster teleconferences will be held following the initial cluster workshop, to review change efforts against action plan, progress change, tailoring to local environment, motivation by opinion leaders, engagement with governance/quality improvement, continue pathway and protocol analysis towards optimal stroke reperfusion workflow, monitor progress via audit and review of process measures including door-to-groin (DTG) time and door-in-door-out (DIDO) time and advanced imaging output to optimise patient selection and hub and spoke transfer of care arrangements.

POST-INTERVENTION PERIOD

No direct encouragement will be provided to sites during the post-intervention period.
Intervention code [1] 313781 0
Treatment: Other
Comparator / control treatment
No treatment (staff intervention) during the control period. There will be no interaction with sites during the control period other than data collection. This is a stepped-wedge design. Each site acts as its own control over time.
Control group
Active

Outcomes
Primary outcome [1] 319266 0
Proportion accessing Endovascular Therapy (EVT) per Cluster (measured at hub hospital using Cluster denominator data).
This outcome will be assessed using de-identified case data entered into the TACTICS electronic case report form by hospital staff at each participating hospital (numerator). Denominator data will be ICD-10 coding of all stroke separations using Cluster denominator data

Timepoint [1] 319266 0
Three months post-intervention period.
Secondary outcome [1] 367495 0
Proportion accessing IVT at spoke hospitals (using denominator data for all spokes/Cluster).
This outcome will be assessed using de-identified case data entered into the TACTICS electronic case report form by hospital staff at each participating spoke hospital (numerator). Denominator data will be ICD-10 coding of all stroke separations for all spokes in a Cluster.
Timepoint [1] 367495 0
Three months post-intervention period.
Secondary outcome [2] 367496 0
Proportion with good functional outcome (modified Rankin scale (mRS) 0-2) of those treated with IVT at spoke hospitals.
Timepoint [2] 367496 0
Measured at three months post-treatment for patients treated during the 3 month post-intervention period.
Secondary outcome [3] 367497 0
Proportion with poor functional outcome (mRS 5-6) of those treated with IVT at spoke hospitals.
Timepoint [3] 367497 0
Measured at three months post-treatment for patients treated during the 3 month post-intervention period.
Secondary outcome [4] 367498 0
Proportion of treated patients with good functional outcome (mRS 0-2) who presented with large vessel occlusion at spoke sites.

Timepoint [4] 367498 0
Measured at three months post-treatment for patients treated during the 3 month post-intervention period.
Secondary outcome [5] 367499 0
Proportion of treated patients with poor functional outcome (mRS 5-6) who presented with large vessel occlusion at spoke sites.
Timepoint [5] 367499 0
Measured at three months post-treatment for patients treated during the 3 month post-intervention period.
Secondary outcome [6] 367500 0
Proportion with good functional outcome (mRS 0-2) of those treated with EVT per Cluster (measured at hub including i) direct to hub patients and ii) spoke to hub patients. Patients transferred from non-TACTICS referral hospitals excluded)”
Timepoint [6] 367500 0
Measured at three months post-treatment for patients treated during the 3 month post-intervention period.
Secondary outcome [7] 367501 0
Proportion with poor functional outcome (mRS 5-6) of those treated with EVT per Cluster (measured at hub including i) direct to hub patients and ii) spoke to hub patients. Patients transferred from non-TACTICS referral hospitals excluded)”
Timepoint [7] 367501 0
Measured at three months post-treatment for patients treated during the 3 month post-intervention period.
Secondary outcome [8] 367502 0
The proportion of stroke patients treated with EVT who had a European Quality of Life Scale (EQ-5D-3L) utility score indicating good health at 3 months post-treatment (measured at hub including i) direct to hub patients and ii) spoke to hub patients. Patients transferred from non-TACTICS referral hospitals excluded).
Timepoint [8] 367502 0
Measured at three months post-treatment for patients treated during the 3 month post-intervention period.
Secondary outcome [9] 367503 0
The proportion of stroke patients at spoke hospitals treated with IVT who had an EQ-5D-3L utility score indicating good health at 3 months post-treatment.
Timepoint [9] 367503 0
Measured at three months post-treatment for patients treated during the 3 month post-intervention period.
Secondary outcome [10] 367504 0
The proportion of stroke patients treated with EVT who had an EQ-5D-3L utility score indicating poor health at 3 months post-treatment (measured at hub including i) direct to hub patients and ii) spoke to hub patients. Patients transferred from non-TACTICS referral hospitals excluded).
Timepoint [10] 367504 0
Measured at three months post-treatment for patients treated during the 3 month post-intervention period.
Secondary outcome [11] 367505 0
The proportion of stroke patients at spoke hospitals treated with IVT who had an EQ-5D-3L utility score indicating poor health at 3 months post-treatment.
Timepoint [11] 367505 0
Measured at three months post-treatment for patients treated during the 3 month post-intervention period.
Secondary outcome [12] 367506 0
Proportion of thrombolysed patients with no identifiable relevant perfusion lesion.
This outcome will be assessed using the de-identified data entered by sites into the electronic case report form by hospital staff. Denominator data will be all stroke cases treated with IVT and entered into the TACTICS electronic case report form by participating hospitals within a Cluster.
Timepoint [12] 367506 0
Measured at three months post-treatment for patients treated during the 3 month post-intervention period.
Secondary outcome [13] 368752 0
Proportion of stroke patients treated with EVT who had symptomatic intracerebral haemorrhage.
Symptomatic intracerebral haemorrhage (sICH) is defined as intracerebral haemorrhage (parenchymal haematoma type 2 - PH2 within 48 hours of treatment) combined with neurological deterioration leading to an increase of greater than or equal to 4 points on the NIHSS from baseline, or the lowest NIHSS value between baseline and 24 hours.
This outcome will be assessed using de-identified data entered by sites into the eCRF by hospital staff. As standard clinical care hospital staff collect follow up data including the NIHSS scale, and assess if there is any haemorrhage in follow up brain images.
Timepoint [13] 368752 0
Measured at three months post-treatment for patients treated during the 3 month post-intervention period.

Eligibility
Key inclusion criteria
A hospital “cluster” will include a “hub” site and at least three “spoke” sites. The hub will consist of a comprehensive stroke centre performing EVT. Hub sites must provide 24 hours 7-day EVT service and be fully accessible to the primary stroke centres. Primary stroke centres must be capable of both on-site IVT administration and be engaged in a “drip and ship” model of patient care. Primary stroke centres must be capable of both on-site IVT administration and be engaged in a “drip and ship” model of patient care.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A “hub” site with a part-time EVT service defined as a service that is bypassed more than 1 day per week.
A “spoke” site unwilling or incapable of undertaking the combination of non-contrast brain CT (NCCT), CT perfusion and CT angiography.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed as all sites receive the intervention under the stepped wedge design.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not Applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The project will use a stepped wedge design with one comprehensive stroke centre "hub" and its primary stroke centre "spoke" sites allocated to each of the required steps. Sites are allocated to ‘step’ on a convenience basis (i.e. not random). After identification of a minimum of 6 hub and spoke “clusters”, establishment of outcome measurement systems, along with Human Research Ethics Committee (HREC) approvals at each cluster, a baseline phase will occur over an initial 3 months with measurement of IVT and EVT proportions using the existing imaging systems and existing models of care.

Following baseline, each cluster will receive the “package intervention” which will occur in the six comprehensive stroke centre (hubs) and their participating primary stroke centres (spokes) with measurement of IVT and EVT continuing. Once the intervention has been operational for 3 months at the centres in each cluster, a 3 month post-intervention period will follow for further measurement of IVT and EVT. The steps each with a 3-month evaluation (post-intervention) period will give a time frame of 18 months to complete the intervention followed by the post-intervention period, e.g. total time for measurement and intervention being 24 months (e.g. Cluster 1 baseline to end of Cluster 6 post-intervention). Each hospital will collect case data across the three study phases: baseline (3 months), intervention (3 months) and post-intervention (3 months)
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Primary outcome: The primary outcome (Proportion accessing EVT per Cluster) will be analysed using a negative binomial mixed effects model, with site as a random effect and intervention as a fixed effect; a time variable will estimate any secular trends.
Secondary outcomes: Given the secondary outcomes are all proportions, the same analytic approach will be taken as with the primary outcome. No adjustment will be made to p-values for the secondary outcomes given they have been specified a priori; instead consistency of results across the good and poor outcomes as rated by mRS and EQ-5D will be checked.
An interim analysis of the baseline prevalence rates only will be performed to check that they are in the range estimated in the sample size calculation. There will be no interim analysis of the effect of the intervention and hence no alpha spending function needed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA

Funding & Sponsors
Funding source category [1] 302095 0
Government body
Name [1] 302095 0
National Health and Medical Research
Address [1] 302095 0
Research Committee Secretariat NHMRC GPO Box 1421 Canberra ACT 2601
Country [1] 302095 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Dr, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 301918 0
Commercial sector/Industry
Name [1] 301918 0
Boehringer Ingelheim
Address [1] 301918 0
Level 1, 78 Waterloo Road
North Ryde, NSW 2113, Australia
PO Box 1969, Macquarie Centre, NSW 2113, Australia
Country [1] 301918 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302774 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 302774 0
Locked Bag No 1, HRMC, NSW, 2310.
Ethics committee country [1] 302774 0
Australia
Date submitted for ethics approval [1] 302774 0
Approval date [1] 302774 0
19/12/2018
Ethics approval number [1] 302774 0
HREC/18/HNE/241

Summary
Brief summary
The TACTICS study will implement a multimodal package, which combines advanced CT imaging with modern post processing methods optimised for stroke, with access to EVT in hub hospitals with the resources to provide the required service and follow-up. This will be combined with a support package of systems improvement resources focused around acute stroke reperfusion pathways and protocols.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91354 0
Prof Christopher R Levi
Address 91354 0
The Sydney Partnership for Health, Education, Research & Enterprise's (SPHERE) office: Level 4, Ingham Institute for Applied Medical Research, 1 Campbell Street, Liverpool NSW 2170
Country 91354 0
Australia
Phone 91354 0
+61 2 8738 8864
Fax 91354 0
Email 91354 0
christopher.levi@unsw.edu.au
Contact person for public queries
Name 91355 0
Ms Martine Cox
Address 91355 0
Priority Research Centre for Health Behaviour. Level 4 West, HMRI Building. Lot 1, Kookaburra Cct, New Lambton Heights NSW 2305
Country 91355 0
Australia
Phone 91355 0
+61 2 4042 0695
Fax 91355 0
Email 91355 0
martine.cox@newcastle.edu.au
Contact person for scientific queries
Name 91356 0
Prof Christopher R Levi
Address 91356 0
The Sydney Partnership for Health, Education, Research & Enterprise's (SPHERE) office: Level 4, Ingham Institute for Applied Medical Research, 1 Campbell Street, Liverpool NSW 2170
Country 91356 0
Australia
Phone 91356 0
+61 2 8738 8864
Fax 91356 0
Email 91356 0
christopher.levi@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not agreed yet. Needs to be formalised with participating sites.
What supporting documents are/will be available?
Study protocol
Ethical approval
Summary results
No Results